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NuVasive 6900429Recalls & reported problems

Nuvasive, Inc. · Universal Rongeur, Pituitary Small · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517385802), received between Aug 31, 2022 and Feb 16, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 16, 2024Fracture; Fracture

    THE PITUITARY RONGEUR WAS INITIALLY REPORTED TO HAVE BROKEN DURING USE IN A PROCEDURE WITH NO ADDITIONAL DETAILS PROVIDED. HOWEVER, DURING ANALYSIS OF THE DEVICE BY THE MANUFACTURER, IT WAS DETERMINED THE DEVICE EXHIBITED A FRACTURED OFF DISTAL TIP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE IN ASSOCIATION WITH THE FRACTURED OFF TIP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18724274 ↗
  • MalfunctionJul 24, 2023Fracture; Fracture

    IT WAS REPORTED THAT WHILE CLEARING THE DISC SPACE DURING A LATERAL PROCEDURE AT L4/5, THE SURGEON NOTICED WHAT APPEARED TO BE A FRAGMENT OF METAL LEFT IN THE DISC SPACE. AFTER CHECKING THE SURGICAL INSTRUMENTS, THE SCRUB NURSE NOTICED THAT THE PITUITARY RONGEUR USED IN THE PROCEDURE WAS MISSING A PIECE OF ITS TIP. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT USING A NERVE HOOK AND ANOTHER PITUITARY RONGEUR. THERE WAS NO SIGNIFICANT DELAY OR ADVERSE IMPACT TO THE PATIENT, USER, OR SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17386198 ↗
  • MalfunctionAug 31, 2022Fracture; Fracture

    ON (B)(6) 2022 A PATIENT UNDERWENT A DISCECTOMY PROCEDURE FROM L5 TO S1. WHILE REMOVING TISSUE BETWEEN THE L5 AND S1 DISC SPACE THE SURGEON COMMENTED THE DISC SPACE WAS QUITE COLLAPSED AND THE UPPER JAW OF THE RONGEUR FRACTURED OFF WHILE ROTATING WITHIN THE DISC SPACE. THE FRACTURED PORTION WAS CONFIRMED TO BE RETRIEVED BY XRAY AND THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15329344 ↗

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Sources and updates

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